Originally Published MPMN July 2006

EDITOR'S PAGE

A Bill May Make Manufacturers Breathe Easier

To date, 130 people have died from the H5N1 virus, known as the avian flu. That's tragic, but it could be much worse. So far the virus has not been transmitted from person to person. But that could change.

In June 2006, the World Health Organization (WHO) reported that the virus has mutated slightly. This was discovered after samples from a family cluster in Sumatra, Indonesia were studied. WHO stresses that this does not mean the disease is closer to becoming pandemic in humans. Still, the threat looms. Who's to say the next change in the virus will be as benign?

Should the worst-case scenario happen, a group of medical device manufacturers is trying to make sure we're ready. On June 24, 2006, the leaders of six respirator makers wrote a letter to President Bush urging him to back legislation ensuring the supply and availability of disposable respirator masks (N-95 respirators) for healthcare workers and other first responders.

The U.S. Centers for Disease Control (CDC) has determined that the minimum requirement for healthcare workers treating patients with H5N1 is an N-95 disposable particulate respirator. And WHO says the respirators are preferred.

The bipartisan bills (S.1406) and (H.R. 2347) would protect American workers and responders by ensuring the continued commercial availability of respirators. It would also establish rules governing product liability actions against manufacturers and sellers of respirators.

This protection is much needed. Although the products are regulated by FDA, as well as the National Institute for Occupational Safety and Health, the industry has been hit with a number of what it calls frivolous lawsuits. This is despite the fact that makers cannot affect how or when the products are used.

"Even though the claims are routinely dropped, dismissed, or settled for very small amounts, the number of cases is overwhelming. Respirator manufacturers' litigation costs in 2004 equaled 90% of the net income earned from selling the products that same year," says Daniel K. Shipp, president of the International Safety Equipment Association. "The industry desperately needs protection from baseless, mass tort claims to allow companies to focus on the business of making respirators to meet the avian flu challenge."

Because of these costs, the manufacturers say they currently have three choices. They can limit production, exit the market, or make their products where there is no litigation crisis. And that's already happening. One major manufacturer has announced that it will no longer produce N-95 masks for the industrial market. Currently both the Senate and House bills are buried in committee, where they have been since 2005. We hope this initiative by the manufacturers will help bring them to the forefront again.

Susan Shepard, Editor

Copyright ©2006 Medical Product Manufacturing News